Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical

NCT05296889 · tracked via the Priya Life Science Germany tracker

Sponsor

Aesculap AG

Phase

Observational

Started

2021-07-21

Last updated

2026-08-03

Condition(s) studied

Spine FractureDegenerative Disc DiseaseSpinal InstabilitySpinal TumorDegenerative Myelopathy

Investigational drug(s) / intervention(s)

posterior stabilization for the cervical spine

posterior stabilization for the cervical spine: The Ennovate® Cervical Spinal System is a posterior stabilization for the cervical and upper-thoracic spine. The implants are used for the posterior monosegmental and multisegmental stabilization of the occipitocervical junction and of the cervical and upper thoracic spine.

Study summary

Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient is minimum 18 years old * Informed Consent in the documentation of clinical and radiological results * Patient has indication according to Instructions for Use (IFU) * Patient is not pregnant Exclusion Criteria: * Patient's clear unability or unwillingness to participate in follow-up examinations

Primary outcome measure(s)

Change of Pain — preoperatively, at 3 months postoperatively and at 12 months postoperatively
Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which states "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain".

Trial sites (4)

Facility	City	Region	Status
Schön Klinik Hamburg Eilbek	Hamburg	Free and Hanseatic City of Hamburg	Active Not Recruiting
Krankenhaus Ludmillenstift Meppen	Meppen	Lower Saxony	Not Yet Recruiting
Städtisches Klinikum Dresden	Dresden	Saxony	Not Yet Recruiting
Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale	Halle	Saxony-Anhalt	Recruiting

More Aesculap AG trials in Germany

MiDura-Study (Neuro-Patch in Duraplasty) Active, not recruiting

Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy Recruiting

Longterm-Evaluation of Vitelene® Against Standard Active, not recruiting

Cemented TrendHip® - Multicenter PMCF Study on Total Indications Active, not recruiting

Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants Recruiting

Other trials for the same condition

PMCF Neo Pedicle Screw and Cage Systems Active, not recruiting

The European Robotic Spinal Instrumentation (EUROSPIN) Study Active, not recruiting

LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant Recruiting

Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05296889 on ClinicalTrials.gov ↗ ← All trials in Germany